Enhancing Safety of Drug-Device Combinations for Cardiovascular Disease: A Focus on Post- Market Safety Surveillance and Regulatory Considerations in the EU and US

• Published in: Drug safety 2023-11, Vol.46 (11), p.1194-1195
• Main Authors: Lines, R, Shelton, K, Dsouza, J, Noss, R
• Format: Article
• Language: English
• Subjects: Biocompatibility; Biomedical materials; Cardiovascular diseases; Decision making; Devices; Drug delivery; Drugs; Global health; Implants; Invasiveness; Marketing; Medical equipment; Medical innovations; Public health; Regulatory agencies; Risk assessment; Safety; Stents; Surveillance; Surveillance systems; Thromboembolism; Thrombosis
• ISSN: 0114-5916; 1179-1942

Introduction: Cardiovascular diseases (CVDs) remain a significant global health concern, necessitating effective post- marketing surveillance of cardiovascular drug-device combination (DDC) products. The integration of drugs, devices, and biologics in DDC products offers promising therapeutic approaches for managing CVD; however, the growing complexity and innovation of DDC products present unique challenges. Aim: To address regulatory challenges and leveraging cardiovascular insights to facilitate the timely identification and resolution of safety concerns in the drug-device combinations used in the treatment of cardiovascular diseases. Method: The structure of this abstract follows a systematic review approach, which involves an examination of current databases such as PubMed, Google Scholar, Embase and regulatory guidelines pertaining to problems with post-market surveillance requirements of drug-device combinations that treat cardiovascular diseases. Results: DDC products, integrating drugs, devices, and biologics, offer innovative therapeutic strategies for managing CVDs1, 2. These products come in diverse forms, such as drug-coated/impregnated devices, drug-eluting stents, and transdermal patches 1, 2. In the EU, manufacturers of Class IIa, IIb, and III devices are mandated to establish a post-market surveillance system and provide periodic safety update reports (PSURs)3. Post- marketing surveillance allows for the assessment of real-world performance, identification of risks, and evaluation of clinical outcomes. If safety concerns are identified through such reporting mechanisms, regulatory bodies will call for corrective measures or may reconsider recalling the products.The case of bioresorbable vascular scaffolds (BVS), a drug-device combination similar to drug- eluting stents, emphasizes the need for more stringent post-market surveillance requirements. Drug- eluting stents are typically categorized as Class III devices in both the EU4 and the US5 given the risk and invasiveness associated with their function. The BVS, also class III, initially showed promising outcomes but later exhibited increased rates of adverse events, such as increased rates of device thrombosis and target- lesion revascularization6. This highlights the importance of proactive monitoring measures and robust reporting standards to identify safety concerns earlier and initiate timely corrective actions. Comprehensive post-marketing surveillance strategies, incorporating regis